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Session 0406 Quality and Integrity of Clinical Trial Data
Session Chair(s)
Daniel Liu, PhD, MSc
President & CSO
Beijing Clinical Service Center, China
Speaker(s)
Qin Huang, PhD
Center For Drug Evaluation, CFDA, China
Deputy Director, Office of Biostatistics
An Emerging Regulatory Landscape Impacting Quality and Integrity of Clinical Data Submission Trial Master File
Daniel Liu, PhD, MSc
Beijing Clinical Service Center, China
President & CSO
Summary level clinical site data for data integrity review and inspection planning in NDA and BLA submission
Jingwei Gao
Boehringer Ingelheim (China) Investment Co., Ltd., China
Regional Head,Regional Statistical Programming – Pan Asia META
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